Last Updated on: 09. Nov 2024
New harmonized standard for MDR: Decision
✅ 26 out of 226 standards harmonized (11.5%)
New harmonized standards for IVDR: Decision
✅ 15 out of 45 standards harmonized (33.3%)
Note: The harmonization of norms regarding the regulations MDR and IVDR is still ongoing. Therefore, this list is not exhaustive and may change over time. It is recommended to keep up-to-date with the official websites of relevant standardization bodies and notified bodies to obtain the most current information.
Most of the european harmonized standards for medical devices are also mentioned by other international authorities. See here for further information.
All Process standards you need for your MDR and IVDR QMS (not all harmonized)
CEN Reference Standard Number, and SNV Reference | Standard Title | MDR harm. Date IVDR harm. Date |
|---|---|---|
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) | OJ L 138 – 17/05/2022 OJ L 135 –12/05/2022, incl. A11 corresponce of to IVDR/MDR. Learn more about this standard here. | |
EN ISO 14155:2011+AC:2011 | Clinical investigation of medical devices for human subjects – Good clinical practice | not harmonised yet, new version published ISO 14155:2020 |
EN ISO 14971:2019, EN ISO 14971:2019/A11:2021 | Medical devices – Application of risk management to medical devices (ISO 14971:2019) | OJ L 138 – 17/05/2022, OJ L 135 – 12/05/2022. Recommended together with ISO/IEC Guide 63 and ISO/TR 24971:2020 – Technical Report – Medical Devices Risk Management. Incl. Amendment A11with IVDR/MDR correspondence. |
n/a | Medical devices — Guidance on the application of ISO 14971 (ISO/TR 24971) | not on the harmonization plan, but essential for the application of ISO 14971:2019 Already in ColabON |
EN IEC 62304:2006+A1:2015 CSV | Medical device software – Software life-cycle processes | not harmonised yet, essential for SW Products |
EN IEC 62366-1:2015+AC:2016 CSV | Medical devices – Application of usability engineering to medical devices | not harmonised yet, but essential |
EN ISO 20916:2024 | In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019) | NEW harmonized since 8. November 2024 for IVDS |
IEC 80001-1:2011 | Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software – Part 1: Application of risk management | not harmonised yet, new international standard published IEC 80001-1:2021 |
IEC 81001-5-1:2021 | Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle (IEC 81001-5-1) | not harmonised yet, international edition published: IEC 81001-5-1:2021 |
IEC 82304-1:2017 | Health Software – Part 1: General requirements for product safety | not harmonised yet. IEC 82304-1:2016 enlarges process requirements for healthcare software, e.g. software not being medical device or ivd |
The Standard Harmonization Plans
Mandate M/575 - C(2021)2406 : 2021-03-12 M/575 Amd 1 – C(2023)694
We have devoted significant effort to ensure the accuracy of this list, although its creation involves meticulous manual work. If you happen to spot any errors, we would greatly appreciate your feedback so that we can make the necessary corrections. We extend our gratitude to SWITEC and SNV for their invaluable expert contributions.
Publications in the Official Journal
Amendment of 4 January 2022 to Implementing Decision (EU) 2021/1182
Amendment of 11 May 2022 to Implementing Decision (EU) 2021/1182
Amendment of 4 July 2023 to Implementing Decision (EU) 2021/1182
Amendment of 6 March 2024 to Implementing Decision (EU) 2021/1182
COMMISSION IMPLEMENTING DECISION (EU) 2024/2631 of 8 October 2024
Current MDR List of Harmonized Standards (Status 8. Nov 2024)
Here is the consolidated list of harmonized standards for medical devices
No | Reference of the standard | Comment |
1. | EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021) |
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2. | EN ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) EN ISO 11135:2014/A1:2019 Published as European Amendment A1: SN EN ISO 11135/A1:2020 |
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3. | EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) EN ISO 11137-1:2015/A2:2019 Published as: SN EN ISO 11137-1/A2:2020 | Applicable for sterile packed products |
4. | EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
Published as: SN EN ISO 11737-2:2020 | Applicable for sterile packed products |
5. | EN ISO 25424:2019 Sterilisation of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 25424:2018) EN ISO 25424:2019/A1:2022 |
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6. | EN ISO 10993-9:2021 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019) |
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7. | EN ISO 10993-12:2021 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021) |
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8. | EN ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018) EN ISO 11737-1:2018/A1:2021 Published as European Amendment A1: SN EN ISO 11737-1/A1:2021 | ISO 11737-1:2018: 3rd edition |
9. | EN ISO 13408-6:2021 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021) |
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10. | EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) EN ISO 13485:2016/AC:2018 EN ISO 13485:2016/A11:2021
Amendment published as: SN EN ISO 13485/A11:2021 | Applicable to all manufacturers of medical devices and ivds
Learn more about this important Amendment 11 here |
11. | EN ISO 14160:2021 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020) |
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12. | EN ISO 15223-1:2021 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
Published as full standard including the European annexes: SN EN ISO 15223-1:2021 | Applicable to all manufacturers of medical devices and ivds |
13. | EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021) |
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14. | EN IEC 60601-2-83:2020 Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment EN IEC 60601-2-83:2020/A11:2021 |
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15. | EN 285:2015+A1:2021 Sterilization – Steam sterilizers – Large sterilizers |
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16. | EN ISO 14971:2019 Medical devices – Application of risk management to medical devices (ISO 14971:2019) EN ISO 14971:2019/A11:2021 Amendment published as: SN EN ISO 14971/A11:2021 | Applicable to all manufacturers of medical devices and ivds |
17. | EN ISO 10993-10:2023 Biological evaluation of medical devices – Part 10: Tests for skin sensitisation (ISO 10993-10:2021) |
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18. | EN 455-3:2023 Medical gloves for single use – Part 3: Requirements and testing for biological evaluation |
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19. | EN ISO 10993-15:2023 Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019) |
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20. | EN ISO 10993-17:2023 Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023) |
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21. | EN ISO 10993-18:2020 Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020) EN ISO 10993-18:2020/A1:2023 |
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22. | EN ISO 11137-2:2015 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013) EN ISO 11137-2:2015/A1:2023
Amendment published as: SN EN ISO 11137-2/A1:2023 | When your medical device is sterile packed with the sterilization method radiation |
23. | EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) EN ISO 11607-1:2020/A1:2023 Amendment published as: SN EN ISO 11607-1/A1:2023 | For all sterile packed medical devices |
24. | EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019) EN ISO 11607-2:2020/A1:2023
Amendment published as: SN EN ISO 11607-2/A1:2023 | For all sterile packed medical devices |
25. | EN ISO 17664-2:2023 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices (ISO 17664-2:2021) |
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26. | EN ISO 13408-1:2024 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023) |
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Where can I find harmonised standards?
Harmonised standards can be found on official websites such as the European Commission's website, which maintains a list of harmonised standards under various regulations, including the MDR (Medical Device Regulation). Additionally, harmonised standards can be accessed through national standardisation bodies such as DIN in Germany, BSI in the UK, or international bodies like ISO and CEN. These sources offer the most up-to-date versions of harmonised standards relevant to various industries, including medical devices.
How to identify a harmonised standard?
To identify a harmonised standard, check the official lists provided by the European Commission. A harmonised standard will have a reference number and be linked to specific EU regulations such as the MDR. It is typically prefixed by "EN" followed by the corresponding ISO or IEC number, indicating that it has been harmonised for use within the European Union to ensure compliance with regulatory requirements. Read the scope to understand the applicability... or get in touch with us...
What are harmonized standards for medical devices?
Harmonised standards for medical devices are specific technical standards that have been harmonised under the EU's Medical Device Regulation (MDR). These standards provide manufacturers with a clear framework to demonstrate compliance with safety and performance requirements. Common harmonised standards for medical devices include EN ISO 13485 for quality management systems and EN ISO 14971 for risk management. These standards help ensure that medical devices meet essential regulatory requirements for the EU market.
What is MDR standards?
MDR standards refer to the harmonised standards that support the Medical Device Regulation (MDR) in Europe. These standards cover various aspects such as quality management, risk management, biocompatibility, and clinical evaluation of medical devices. Following MDR standards helps manufacturers ensure that their medical devices comply with EU regulatory requirements, making them eligible for CE marking and placement on the European market.
Prominent Voids in Harmonised Standards Medical Device
Here are a few important standards from the top of my head that are missing on the list of harmonised standards. These are quite crucial standards that have a direct impact on patient safety. 🩺
ISO 10993-1: Biocompatibility 🧬
IEC 62366-1: Usability 📋
IEC 62304: Software Development 💻
IEC 60601-1: Medical electrical equipment ⚡
IEC 60601-1-2: EMC 🌐
Best Practices
Involve your notified body early
Discuss this topic with pears from other companies
Use the harmonised standards whenever available, else use the FDA consensus standards
ColabON: Access to all data at clause level
With ColabON, you gain access to all relevant norms and regulations for the medical device / in vitro diagnostic industry in a structured and easily understandable format. The data is provided at clause level, enabling you to conduct precise and detailed analysis.
Get the current and planned harmonized standard list for medical devices and ivds
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